Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
NCT03319940 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 269
Last updated 2025-11-19
Summary
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
Conditions
- Small Cell Lung Carcinoma
Interventions
- DRUG
-
Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
- DRUG
-
CRS Mitigation Strategies
Participants will be treated with one of the CRS mitigation strategies.
- DRUG
-
Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-26
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- France
- Germany
- Hong Kong
- Japan
- Netherlands
- Poland
- Spain
- Switzerland
- Taiwan
- United Kingdom
Study Locations
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